Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-27 @ 2:04 PM
Study NCT ID:
NCT00713167
Status:
COMPLETED
Last Update Posted:
2009-05-21
First Post:
2008-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Red Grape Seed Extract on Lipid Profile and Oxidized Low-Density Lipoprotein (OX-LDL)
Sponsor:
Shahid Beheshti University of Medical Sciences
Organization:
Study Overview
Official Title:
Randomized, Cross-Over, Double Blind, Placebo-Controlled Study of Grape Seed Extract in Treating Patients With Mild Hyperlipidemia
Status:
COMPLETED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GSE
Brief Summary:
Antioxidants are potent scavengers of free radicals and serve as inhibitors of neoplastic processes. A large number of synthetic and natural antioxidants are known to induce beneficial effects on human health and disease prevention. Cardioprotective ability of grape seed extract polyphenols (GSEP) was studied in animals and humans. It has been suggested that grape seed proanthocyanidins have cardioprotective effects against reperfusion-induced injury of free radicals after ischemia. In another study, it is suggested that proanthocyanidins, the major polyphenols in red wine, might trap reactive oxygen species in aqueous series such as plasma and interstitial fluid of the arterial wall; thereby inhibiting oxidation of low-density lipoprotein (LDL) and showing an antiatherosclerotic activity. The only human model study designed to evaluate the effect of a standardized formulation of a GSEP (leucoselect-phytosome \[LP\]) on the susceptibility of LDL to oxidation in a group of heavy smokers, revealed that the antioxidant potential of GSEP may be effective in oxidative stress (smoking); however more investigational data are needed before wider use in clinical settings. Based on these observations, the investigators decided to evaluate the effect of GSEP in reducing OX-LDL in patients diagnosed with mild hyperlipidemia.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: